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Two cycles of risk-adapted consolidation therapy in patients with acute promyelocytic leukemia. Results from the SAL-AIDA2000 trial

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Abstract

The combination of all-trans retinoic acid (ATRA) and idarubicin (AIDA) for induction therapy followed by three cycles of risk-adapted consolidation cycles is considered standard of care for patients with acute promyelocytic leukemia (APL). We report the outcome of 141 patients (median age 51 years; range, 19–82, 31 % ≥60 years) enrolled into the prospective Study Alliance Leukemia (SAL)-AIDA2000 trial, which comprised AIDA-based induction followed by only two courses of risk-adapted consolidation (daunorubicin or mitoxantrone ± cytarabine) followed by 2-year maintenance treatment. The early death rate was 7 % (median age 66 years), and additional 9 % stopped further treatment after induction. The estimated 6-year disease-free survival (DFS) was 80 % in all patients, 84 % in patients ≤60 and 72 % in patients >60 years (p = 0.140). No significant survival differences were observed between the high-risk and the non-high-risk patients (6-year OS 78 vs. 81 %, p = 0.625). Our results confirm the efficacy of a risk-adapted approach in APL patients. Furthermore, long-term outcomes are comparable to the results obtained with three cycles of consolidation. A modification of the number and intensity of conventional consolidation treatment may be a less toxic but equally effective approach and should be considered for further evaluation in randomized clinical trials in APL.

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Acknowledgments

We thank S. Helas for assistance in formatting the figures. UP is supported by a grant within the SFB 655 from the Deutsche Forschungsgemeinschaft (DFG).

Authors’ contributions

UP, US, GE, MS and CR designed the study, collected, analyzed and interpreted data, and wrote the manuscript. MK collected, analyzed and interpreted data and edited the manuscript. All other authors interpreted data and edited the paper. Presented in part as an abstract at the 53rd Annual Meeting of the American Society of Hematology, San Diego, CA, USA, December 12, 2011.

Conflict of interest

The authors declare that they have no conflict of interest.

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Authors and Affiliations

  1. Medizinische Klinik und Poliklinik I, Universitätsklinikum Dresden, Fetscherstraße 74, 01307, Dresden, Germany

    Christoph Röllig, Michael Kramer, Christian Thiede, Uta Oelschlägel, Brigitte Mohr, Martin Bornhäuser, Gerhard Ehninger, Ulrich Schuler & Uwe Platzbecker

  2. 5. Medizinische Klinik, Klinikum Nürnberg, Nürnberg, Germany

    Kerstin Schäfer-Eckardt

  3. Klinik für Innere Medizin III, Klinikum Chemnitz, Chemnitz, Germany

    Matthias Hänel

  4. Klink für Hämatologie, Onkologie und Palliativmedizin, Rems-Murr-Kliniken, Winnenden, Germany

    Markus Schaich

  5. Universitätsklinikum Lübeck, Lübeck, Germany

    Thomas Wagner

  6. Medizinische Klinik und Poliklinik II, Universitätsklinikum Würzburg, Würzburg, Germany

    Hermann Einsele

  7. Medizinische Klinik 5, Universitätsklinikum Erlangen, Erlangen, Germany

    Stefan W. Krause

  8. Fachabteilung Onkologie, Hämatologie, Hämostasiologie und Palliativmedizin, Johannes Wesling Klinikum Minden, Minden, Germany

    Heinrich Bodenstein

  9. Abteilung für Hämatologie, Onkologie und Palliativmedizin, Robert-Bosch-Krankenhaus, Stuttgart, Germany

    Sonja Martin

  10. Abteilung für Hämatologie und Stammzelltransplantation, Asklepios Klinik St. Georg, Hamburg, Germany

    Reingard Stuhlmann

  11. Medizinische Klinik V, Universitätsklinikum Heidelberg, Heidelberg, Germany

    Antony D. Ho

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  1. Christoph Röllig
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  2. Kerstin Schäfer-Eckardt
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  6. Christian Thiede
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  7. Uta Oelschlägel
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  8. Brigitte Mohr
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  9. Thomas Wagner
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  11. Stefan W. Krause
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  12. Heinrich Bodenstein
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  13. Sonja Martin
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  14. Reingard Stuhlmann
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  15. Antony D. Ho
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  16. Martin Bornhäuser
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  17. Gerhard Ehninger
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  18. Ulrich Schuler
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  19. Uwe Platzbecker
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Correspondence to Uwe Platzbecker.

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Röllig, C., Schäfer-Eckardt, K., Hänel, M. et al. Two cycles of risk-adapted consolidation therapy in patients with acute promyelocytic leukemia. Results from the SAL-AIDA2000 trial. Ann Hematol 94, 557–563 (2015). https://doi.org/10.1007/s00277-014-2242-6

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  • DOI: https://doi.org/10.1007/s00277-014-2242-6

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